RECRUITINGPhase 3

VItamin D in pregnanCy for prevenTion Of eaRlY Childhood Asthma

The overall aim of the study is to develop a nutritional preventive vitamin D supplementation strategy in pregnancy for early childhood asthma/persistent wheeze during the first three years of life as we hypothesize that supplementation in higher doses than recommended could reduce the risk of disease development.

Sponsor

Professor Klaus Bønnelykke

Enrollment

2,000 participants

Sites

1 locations

Start Date

December 2024

Completion

October 2026

AsthmaRespiratory Tract InfectionsGastrointestinal InfectionCroupEczema

Enrollment & Timeline

Recruiting

Target enrollment (estimated)

Target N

2,000

participants

Sites

locations

Duration

8.3 years

total trial span

Rate

pts/month needed

Dec 2024Month 18 of 99Oct 2026

18% of trial timeline elapsed81 months to primary endpoint

At 1 sites, each site needs to enroll approximately 20.0 patients/month to hit the enrollment target on schedule.

Enrollment target is estimated. ClinicalTrials.gov does not provide real-time enrollment progress.

View on ClinicalTrials.gov

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Primary Outcomes

Early childhood asthma/persistent wheeze age 0-3 years

3 years

Defined as either a) parental report of a minimum of 2 wheeze episodes with at least 1 after the child's second birthday and redemption of at least 2 prescriptions of asthma controller medication with at least 1 being after the child's second birthday or b) a minimum of 2 ED visits or hospitalizations due to asthmatic symptoms, and at least 1 of these being after the child's second birthday or c) parental report of physician-diagnosed asthma age 0-3 years Outcome analysis: risk (survival analysis) of persistent wheeze or asthma at age 0-3 years.

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Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

Fish oil and vitamin D in pregnancy for the prevention of early childhood asthma: study protocol for two double-blinded, randomised controlled trials.

Brustad Nicklas, Vahman Nilo, Ralfkiaer Ulrik et al.BMJ open2024

DOI PubMed

PubMed/NCBI (daily updates) FDA FAERS (quarterly updates) WHO ICTRP (weekly updates)

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Fetching protocol from ClinicalTrials.gov…

RECRUITINGPhase 3

VItamin D in pregnanCy for prevenTion Of eaRlY Childhood Asthma

Sponsor

Professor Klaus Bønnelykke

Enrollment

2,000 participants

Sites

1 locations

Start Date

December 2024

Completion

October 2026

AsthmaRespiratory Tract InfectionsGastrointestinal InfectionCroupEczema

Enrollment & Timeline

Recruiting

Target enrollment (estimated)

Target N

2,000

participants

Sites

locations

Duration

8.3 years

total trial span

Rate

pts/month needed

Dec 2024Month 18 of 99Oct 2026

18% of trial timeline elapsed81 months to primary endpoint

At 1 sites, each site needs to enroll approximately 20.0 patients/month to hit the enrollment target on schedule.

Enrollment target is estimated. ClinicalTrials.gov does not provide real-time enrollment progress.

View on ClinicalTrials.gov

Ask AI

Primary Outcomes

Early childhood asthma/persistent wheeze age 0-3 years

3 years

Ask AI

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

Fish oil and vitamin D in pregnancy for the prevention of early childhood asthma: study protocol for two double-blinded, randomised controlled trials.

Brustad Nicklas, Vahman Nilo, Ralfkiaer Ulrik et al.BMJ open2024

DOI PubMed

PubMed/NCBI (daily updates) FDA FAERS (quarterly updates) WHO ICTRP (weekly updates)

Ask AI

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

female

Healthy Volunteers

Yes

View full criteria

* Pregnant Danish women before week 26 with blood levels of EPA+DHA above 4.7% of total fatty acids
* No current vitamin D intake above the recommended 400 IU/day
* No endocrine-, heart-, kidney- or auto-immune disorders
* No disorders requiring treatment with blood thinning medication

VItamin D in pregnanCy for prevenTion Of eaRlY Childhood Asthma

Enrollment & Timeline

Primary Outcomes

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

VItamin D in pregnanCy for prevenTion Of eaRlY Childhood Asthma

Enrollment & Timeline

Primary Outcomes

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

Eligibility

Trial Sites (1)